Horizon 2020 New Opportunities for Clinical Research in Europe

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1 Horizon 2020 New Opportunities for Clinical Research in Europe Ruxandra Draghia Akli, MD, PhD Director, Health Research DG Research and Innovation European Commission Electronic Health Records for Clinical Research 8

2 FP7 'Health' Building on experience 1,000 projects 11,000 teams 3,500 organisations 130 countries 6 billion EU investment Electronic Health Records for Clinical Research 9

3 Moving on to the next level - Horizon 2020 The EU s programme for research and innovation A core part of Europe 2020, Innovation Union & European Research Area Responding to the economic crisis to invest in future jobs and growth Addressing people s concerns about their livelihoods, safety and environment Strengthening the EU s global position in research, innovation and technology Electronic Health Records for Clinical Research 10

4 Three priorities Leadership in enabling and industrial technologies Access to risk finance Innovation in SMEs Industrial leadership Excellent science Societal challenges European Research Council Future and Emerging Technologies Marie Skłodowska-Curie actions Research infrastructures Health, demographic change and wellbeing Food security, sustainable agriculture and forestry, marine and maritime and inland water research and the Bio economy Secure, clean and efficient energy Smart, green and integrated transport Climate action, environment, resource efficiency and raw materials Inclusive, innovative and reflective societies Secure societies Science with and for society Spreading excellence and widening participation Electronic Health Records for Clinical Research 11

5 The challenge Ageing population Increased disease burden Health and care sector under pressure to reform Electronic Health Records for Clinical Research 12

6 The direction Translate science into better health outcomes A competitive health and care sector New health and care models and tools Healthy and active ageing Electronic Health Records for Clinical Research 13

7 A new approach Research and innovation: From bench to bedside From vertical themes to horizontal challenges Broad, less prescriptive, 2- year work programme Stronger focus on end users Electronic Health Records for Clinical Research 14

8 Work Programme 2014/ calls for proposals: stage 1 closed on 11 March, single-stage deadline 14 April! 1,2 billion of EU funding for health research and innovation 34 'personalising health and care' topics 16 'co-ordination activities' topics Two 'inducement prizes' Electronic Health Records for Clinical Research 15

9 'Clinical trials/clinical studies' topics in WP 2014/2015 PHC : Health promotion and disease prevention: translating 'omics' into stratified approaches PHC : Evaluating existing screening and prevention programmes PHC /2015: Clinical validation of biomarkers and/or diagnostic medical devices (SME instrument!) PHC : New therapies for chronic non-communicable diseases PHC : New therapies for rare diseases Electronic Health Records for Clinical Research 16

10 'Clinical trials/clinical studies' topics in WP 2014/2015 PHC /2015: Clinical research on regenerative medicine PHC : Comparing the effectiveness of existing healthcare interventions in the elderly PHC : Establishing effectiveness of health care interventions in the paediatric population PHC : Developing and comparing new models for safe and efficient, prevention-oriented health and care HCO : Global Alliance for Chronic Diseases: prevention and treatment of type 2 diabetes Electronic Health Records for Clinical Research 17

11 SMEs welcome! Some 20% of the total budget for societal challenges/leits to go to SMEs Simplification a great benefit 'Access to risk finance' with strong SME focus (debt and equity facility) New SME instrument Electronic Health Records for Clinical Research 18

12 Focus on clinical trials Essential if we are to innovate more Needed: more + more professional academic clinical trials 2014/15: Over 300 million of funding earmarked for clinical trials Focus on comparative effectiveness will help drive down health and care costs Electronic Health Records for Clinical Research 19

13 Getting you started faster A single set of simpler and more coherent participation rules Just 2 funding rates (70% or 100%) Single flat rate (25%) for overhead or 'indirect costs' Simpler financial regulation to come 8 months time-to-grant target Electronic Health Records for Clinical Research 20

14 Wanted: international cooperation A priority Key goal: more and better international cooperation Horizon 2020 is open to participation from across the world Targeted actions across the entire programme Horizon 2020 Regulation and Rules for Participation apply Participants from USA can be funded in SC1 (but not other SCs) Electronic Health Records for Clinical Research 21

15 Innovative Medicines Initiative billion EUR, equally shared between public and private partners For breakthrough vaccines, medicines and treatments Including clinical trials (all phases)! For top quality research and innovation with great public health benefits and commercial possibilities Electronic Health Records for Clinical Research 22

16 EDCTP 2 Broader scope: including neglected infectious diseases, all clinical phases, diagnostics and delivery optimisation Funding for phase I to phase IV clinical trials More EU co-funding: almost 700 million EUR Longer duration: 10 years Electronic Health Records for Clinical Research 23

17 Learn more & take part! Electronic Health Records for Clinical Research 24

18 HORIZON 2020 Thank you for your attention! Electronic Health Records for Clinical Research 25